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UK and EU life sciences regulatory update: medical devices reform, point-of-care manufacture, HTA, branded medicines pricing, AI imaging, GDPR transparency, hemp THC, CMA merger control guidance

Published on: 24 October 2024

Published by a LexisNexis Life Sciences expert
Legal News
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In this issue:

  • Medical devices
  • Pharmaceuticals—regulatory framework
  • Borderline products
  • Research and development
  • Data protection and life sciences
  • Competition in life sciences
  • Daily and weekly news alerts
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Medical devices

Parliament lays draft SI to enhance patient and medical devices safety

The UK Parliament has laid a draft statutory instrument (SI) to implement the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, aimed at strengthening patient safety. The reforms will boost traceability of incidents and trend reporting, set out clearer, risk‑proportionate obligations to improve device safety, and introduce a new risk‑based classification model. This will enable patients to access a wider range of medical devices already approved for use in other countries. The SI proposes a six‑month lead‑in period once parliamentary procedures have finished. The regulation is expected to take effect in 2025. See: LNB News 23/10/2024 15.

Legislation alert: Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 SI 2024/Draft

These draft Regulations set out more rigorous and clearer post‑market surveillance duties that are proportionate to risk, with improved regulatory oversight...

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